Trends, Challenges and Outlook in Analysis & Quality Control

Today’s pharmaceutical industry is in a constant state of change, proactively and reactively adjusting pipelines and production while optimizing efficiency and bottom line in global markets buffeted by the pandemic, supply chain, regulatory, and demand uncertainties. Given the rapidly evolving pharma value chain in this turbulent environment, we felt it was an appropriate time to gather the thoughts of those working in pharmaceutical analysis and quality control to uncover the main challenges and trends.

MilliporeSigma and The Analytical Scientist partnered on the development of a benchmarking survey including over 200 Pharma Analysis & QC experts balanced across regions, functions, roles, and company types.

The survey respondents identified a number of important pharma industry trends as well as multiple challenges and suggested improvements within the pharma Analysis & QC and method development areas that reflect major industry trends in throughput, reliability, efficiency, and modernization. The areas of major interest ranged widely from lab management, to technological improvement, to environmental issues.

In this webinar, you will discover how your company compares to others in envisioning trends and addressing challenges. And also, our experts will provide some useful insight to embrace successfully future trends and address major challenges.

Future of Robotics & Automation in Quality Control

The pharmaceutical industry is evolving towards automated, intensified and real-time-monitored production processes. Quality control equally needs to adapt to meet the requirements of productivity, data integrity and reliability of Pharma 4.0. The webinar will detail how automation of microbial testing in the lab through the use of robotics and digital tools will transform the QC process. The benefits of automating QC will be explored, with quantitative estimations based on real cases. Attendees will learn how Millipore Sigma has engaged into driving this transformation by creating optimized solutions combining the benefits of our industry-leading products and those of automation. The webinar will focus mostly on the bioburden workflow as a use case for automation.

How the Choice and Use of Reference Materials Can Improve the Quality of Your Analytical Workflow

The Advanced Analytical portfolio offered by MilliporeSigma, branded as Supelco®, is a group of products that individually and together make end user’s lives easier. The Supelco® portfolio includes a wide range of columns, accessories, and consumables used in all analytical applications as well as a robust offering of reference materials. Reference materials are a critical component of the laboratory’s quality system. From calibration of measurement systems to validation of methods, reference materials ensure accuracy in testing. Different terminologies between pharmaceutical (compendial) and non-pharmaceutical (ISO) reference materials can lead to confusion in determining the best fit-for-purpose reference, potentially impacting accuracy of the testing method. In this presentation, important concepts from metrological traceability, SI unit of measurement and certificate of analysis will be discussed along with the different quality grades of reference materials and how selection of the proper quality grade can ensure optimal fit-for-purpose and testing accuracy. Traceability, certification, stability, and workflow application examples will be provided.

Filtration in Dissolution Testing: Improving Throughput and Reducing Variability

In vitro dissolution testing is used to characterize drug compounds throughout their development. In early drug development it is used to support the choice of a particular formulation. During drug production it is a critical component of the quality control process and is used to assess the changes in manufacturing processes or formulation. In order for dissolution results to be meaningful at each stage, the test and the process need to be reliable, consistent, predictive and accurate.

Filtration as the only sample preparation step plays an important role in the dissolution process, yet this step is often taken for granted. The choice of frits or syringe filters is often based on experience with previous formulations or availability in the lab. Selecting the wrong filter can result in inadequate filtration, low analyte recovery, solvent incompatibility or extractables that reduce accuracy and reproducibility. The wrong pore size or device can result in clogging that can adversely affect throughput and sample processing.

This seminar describes different membrane characteristics and provides guidance in selecting the right filtration devices for sample preparation following in vitro dissolution. Problems that result from using the wrong filter are presented along with steps one can take to solve each problem. Filter characteristics that affect drug recovery and downstream analysis, such as non-specific binding and extractable levels, are presented. Steps one can take to optimize throughput and reduce downtime are addressed including a discussion on membrane properties and guidance on the use of multi-layer and automation compatible filters. Recommendations are presented for choosing the right sample preparation device that will help improve throughput, reduce sample processing time and enhance test accuracy and reproducibility.